Table 1.
Clinical Activity of Nivolumab in Melanoma by Dose Level
| Dose (mg/kg) | ORR* |
Duration of Response (weeks)† |
Stable Disease ≥24 Weeks |
PFS (months) |
OS (months) |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n/N | % | 95% CI | Median | Individual Responses | n/N | % | 95% CI | Median | 95% CI | Median | 95% CI | |
| All doses | 33/107 | 30.8 | 22.3 to 40.5 | 104 | — | 7/107 | 6.5 | 2.7 to 13.0 | 3.7 | 1.9 to 9.1 | 16.8 | 12.5 to 31.6 |
| 0.1‡ | 6/17 | 35.3 | 14.2 to 61.7 | NR§ | 24.1, 24.1, 34.3, 44.1+, 48.1+, 48.7+ | 0 | 0 | 0 | 3.6 | 1.7 to 9.1 | 16.2 | 8.6 to NE |
| 0.3‡ | 5/18 | 27.8 | 9.7 to 53.5 | NR§ | 18.4, 44.4+, 64.6+, 65.1+, 66.3+ | 1/18 | 5.6 | 0.1 to 27.3 | 1.9 | 1.8 to 9.3 | 12.5 | 7.7 to NE |
| 1 | 11/35 | 31.4 | 16.9 to 49.3 | 104 | 32.4, 32.4, 43.0+, 64.1+, 74.1+, 80.1+, 82.1+, 99.4, 100.9+, 104.1, 108.1+ | 5/35 | 14.3 | 4.8 to 30.3 | 9.1 | 1.8 to 24.7 | 25.3 | 14.6 to NE |
| 3 | 7/17 | 41.2 | 18.4 to 67.1 | 75.9 | 40.1+, 40.4, 48.1, 56.1, 95.7, 106.7+, 115.4+ | 1/17 | 5.9 | 0.1 to 28.7 | 9.7 | 1.9 to 16.4 | 20.3 | 8.2 to NE |
| 10 | 4/20 | 20.0 | 5.7 to 43.7 | 112 | 73.9, 78.3+, 111.7, 117.0+ | 0 | 0 | 0 | 3.7 | 1.7 to 20.5 | 11.7 | 7.2 to 37.8 |
Abbreviations: NE, not estimable; n/N, No. of patients/total No. of patients; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression-free survival.
Objective response rates {[(CR + PR) ÷ N] × 100} have been calculated on the basis of confirmed responses with CIs calculated by using the Clopper-Pearson method. Individual patient responses were adjudicated per Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 with modification. One complete response was noted.
Kaplan-Meier estimate, time from first response to time of documented progression, death, or for censored data (denoted by “+”), time to last tumor assessment.
Five patients with tumor progression received dose-escalation from 0.1 to 1.0 mg/kg, and six patients received dose-escalation from 0.3 to 1.0 mg/kg. None of these patients responded to therapy.
The time point at which the probability that responder's progress drops below 50% has not been reached because of insufficient number of events and/or follow-up.